Stem Cells for Treating Critical Ischemia

June 12, 2008 updated by: Instituto de Molestias Cardiovasculares

the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia

Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: stem cells transplant

Detailed Description

About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- Sao Paulo
  - São José do Rio Preto, Sao Paulo, Brazil, 15015-210
    - Recruiting
    - Instituto de Molestias Cardiovasculares
    - Contact:
      
      Jose D Araujo, MD
      
      Phone Number: 112 551732034000
      
      Email: imc.terapia.celular@terra.com br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Fontaine's classification grade 3 and 4 patients

Exclusion Criteria:

Record of cancer in the last 5 years
Over 80 years
Diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Suppress pain and heal ischemic ulcers Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
improve quality of life Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Molestias Cardiovasculares

Investigators

Principal Investigator: Jose D Araújo, MD, Instituto de Molestias Cardiovasculares

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Anticipated)

June 1, 2007

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 12, 2008

Last Verified